Effect of Oxygenated Mouthwash and Mouth Foam on Oral Health and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gingival index
研究概览
简要总结
The Aim of this independent, parallel, twelve-week clinical study is to assess the efficacy of a commercially available oxygenated mouth rinse and mouth foam on both plaque level and gingival status in addition to assessing the oral health related quality of life.
详细描述
Participants in all groups will be examined for gingival inflammation and plaque accumulation. The difference between three trial arms lies in the product used (control, oxygenated mouth wash, oxygenated mouth foam). A comparison against no intervention was disregarded due to ethical concerns (children only examined without informing them about their oral problems). After examination at baseline participants will be assigned to one arm of intervention. All participants will be provided an oral health education and gingival scaling to remove any underlining predisposing factor for gingival inflammation as well as fluoridated toothpaste and a toothbrush. Participants within intervention arms will also be provided the product package and informed how to use it (oxygenated mouth wash, oxygenated mouth foam).
All three arms will be followed after (1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks) from baseline examination.
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Control group Won't receive an oxygenated mouthwash nor oxygenated mouth foam (20 participants) 2. Intervention Group A: 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months (40 bottles in total).
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Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
due to ethical consideration participants cannot be blinded nor examiners as they will be providing oral hygiene instructions and information relative to using the mouth rinse and the mouth foam. everyone handling the data after examination will be blinded, they will be dealing with data obtained after identifying an identification code to each participant.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students and employees at College of applied Medical science over 19 years old
- •Both Saudis and non-Saudis.
- •Students and employees consenting to participate.
排除标准
- •Intern students or students in their 1st year.
- •Students and employees with medically compromised condition (including congenital heart disease, hematological condition, immune deficiency condition and end stage renal disease or those with organ transplant within the previous 5 year.
- •Students and employees not consenting to participate.
结局指标
主要结局
Gingival index
时间窗: +12 weeks from baseline
Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis.
Plaque index
时间窗: +12 weeks from baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
次要结局
- Gum Health Experience Questionnaire (GHEQ)(+12 weeks from baseline)